Practice Areas

Antibacterial Soaps Would Need Further Data to Prove Safety Under FDA Proposal

Wednesday, December 18, 2013

Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is requesting comments no later than June 16, 2014, on a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to demonstrate via clinical studies that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Absent such a demonstration these products would need to be reformulated (by removing the antibacterial active ingredients) or relabeled (by removing the antibacterial claim from the labeling) to remain on the market. The proposal covers only those consumer antibacterial soaps and body washes that are used with water and does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.

The FDA notes that while many consumers use over-the-counter antibacterial soap products believing they will reduce the risk of getting sick or spreading germs, there currently is no evidence that such products are any more effective at preventing illness than washing with plain soap and water. In fact, new data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits. For example, almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the chemical ingredients addressed in this rule (the most commonly used being triclosan, which is regulated by the Environmental Protection Agency as a pesticide and is typically found in liquid soaps, and triclocarban, often used in bar soaps), which may contribute to bacterial resistance to antibiotics and have unanticipated hormonal effects. Given these concerns and the widespread consumer use of antibacterial products, the FDA is re-evaluating what data are needed to classify the active ingredients in these products as “generally recognized as safe and effective.”